An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia
1. Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001 (Time Frame - Up to 28 days): Frequency, severity, relationship and persistence of adverse events (AEs) and dose-limiting toxicity (DLTs)
2. Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 (Time Frame - Up to 3 months): Composite complete response rate (cCRR) defined as the proportion of patients with best overall response, as assessed by Independent Review Committee (IRC) based on European LeukemiaNet (ELN) 2022 criteria, at complete remission (CR), CR with partial haematologic recovery (CRh), or CR with incomplete haematologic recovery (CRi).
Secondary outcome:
1. Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001 (Time Frame - Up to 3 months): Complete remission rate (CRR) defined as the proportion of patients with best overall response, as assessed by IRC based on ELN 2022 criteria, at CR.
2. Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 (Time Frame - Up to 3 months): cCRR
3. Phase 2: To assess the safety of CCTx-001 (Time Frame - Up to 15 years): Frequency, severity, relationship and persistence of AEs
4. Phase 2: To assess HRQoL for patients treated with CCTx-001 (Time Frame - Up to 6 months): Changes in Health-related quality of life (HRQoL) using global health/QoL, fatigue, physical and cognitive functioning subscales of the EORTC quality of life questionnaire-C30 (QLQ-C30)
5. Phase 2: To assess HRQoL for patients treated with CCTx-001 (Time Frame - Up to 24 months): Changes in Health-related quality of life (HRQoL) using the Hematological Malignancy specific Patient Reported Outcome Measures (HM-PRO) tools
6. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 3 months): Objective response rate (ORR)
7. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): event-free survival (EFS)
8. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): relapse-free survival (RFS)
9. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 15 years): overall survival (OS)
10. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): duration of response (DOR)
11. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): cumulative incidence of relapse (CIR)
12. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): cumulative incidence of death (CID)
13. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 24 months): time to composite complete response (TTcCR)
14. Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 (Time Frame - Up to 3 months): time to response (TTR) according to ELN 2022 criteria and minimal residual disease (MRD) responses
15. Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001 (Time Frame - Up to 15 years): Frequency and severity of AEs and laboratory abnormalities
CCTx-001: Frozen CAR T-cells suspensions in media containing dimethyl sulfoxide (DMSO)
Quelle: ClinicalTrials.gov
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"An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia"
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